Gastric Cancer
Conditions
Keywords
Stomach cancer, Palliative chemotherapy, Capecitabine, S-1
Brief summary
A significant proportion of advanced gastric cancer (AGC) occurs in individuals 65 years of age and older. In addition, patient delay in seeking care for symptoms results in diagnosis at a more advanced stage than that seen in younger individuals. However, clinical trials on gastric cancer rarely have been available to the elderly. Recently oral 5-FU pro-drugs, which have been reported to have clinically significant response rates and survival with mild or negligible toxicities, have been widely used for the patients with AGC. However, few studies have been conducted in elderly patients.
Interventions
DRUGS-1
DRUGCapecitabine
Sponsors
Asan Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Pathologically proven gastric or gastroesophageal junction adenocarcinoma * Metastatic or recurrent unresectable disease * Measurable lesions (according to Response Evaluation Criteria in Solid Tumors \[RECIST\]) * Age: 65-85 years old * Performance status: Eastern Cooperative Oncology Group (ECOG) 0-2 * Adequate bone marrow function: absolute neutrophile counts(ANC) ≥ 1,500/ul, platelet count ≥ 100,000/ul, hemoglobin ≥ 9 g/dl) * Adequate renal function (serum creatinine≤ 1.5) * Adequate liver function (serum bilirubin ≤ 2 x upper limits of normal \[UNL\], aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 3 x UNL) * No prior chemotherapy (but adjuvant chemotherapy completed at least 1 year prior to study treatment is allowed with the exception of capecitabine or S-1) Written informed consent was signed by the patient
Exclusion criteria
* Previous palliative chemotherapy * Known allergy to study drugs * CNS metastasis * Significant medical comorbidities * Active ongoing infection which antibiotic treatment is needed. * Previous ( within 5 years) history of other malignancy except cured non-malignant skin cancer and uterine cervical cancer in situ.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response Rate | Up to 2 years | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR; Progressive disease (PD), \>20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD), Insufficient change to qualify for PR or PD Response rate is defined as the proportion of patients who showed OR. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Adverse Events | Up to 2 years | Per National Cancer Institute Common Toxicity Criteria Version 2.0, up to 2 years |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| S-1 for 2 Weeks on/1 Week Off S-1 was given orally two times daily for 28 days, followed by 14 days' rest. Three dosage levels of S-1 were defined according to body surface area (BSA) as follows: BSA less than 1.25 m2, 40mg two times daily; BSA, 1.25 to 1.5 m2, 50 mg, two times daily; and BSA more than 1.5 m2, 60 mg two times daily. | 45 |
| Capecitabine 2 Weeks on/1 Week Off Capecitabine 2500 mg square meter was administered orally in two divided doses daily on days 1-14 of a 21-day cycle. | 46 |
| Total | 91 |
Baseline characteristics
| Characteristic | S-1 for 2 Weeks on/1 Week Off | Capecitabine 2 Weeks on/1 Week Off | Total |
|---|---|---|---|
| Age, Customized Age_median | 71 years | 71 years | 71 years |
| Region of Enrollment Korea, Republic of | 45 participants | 46 participants | 91 participants |
| Sex: Female, Male Female | 8 Participants | 16 Participants | 24 Participants |
| Sex: Female, Male Male | 37 Participants | 30 Participants | 67 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 42 / 42 | 44 / 44 |
| serious Total, serious adverse events | 0 / 42 | 0 / 44 |
Outcome results
Primary
Response Rate
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR; Progressive disease (PD), \>20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD), Insufficient change to qualify for PR or PD Response rate is defined as the proportion of patients who showed OR.
Time frame: Up to 2 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| S-1 for 2 Week on/1 Week Off | Response Rate | 28.9 percentage of participants |
| Capecitabine 2 Weeks on/1 Week Off | Response Rate | 26.1 percentage of participants |
Secondary
Number of Patients With Adverse Events
Per National Cancer Institute Common Toxicity Criteria Version 2.0, up to 2 years
Time frame: Up to 2 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| S-1 for 2 Week on/1 Week Off | Number of Patients With Adverse Events | 42 participants |
| Capecitabine 2 Weeks on/1 Week Off | Number of Patients With Adverse Events | 44 participants |